RecruitingNot ApplicableNCT05540223

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System

BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve®) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries: BIOMAG-II: A Randomized Controlled Trial

Sponsor

Biotronik AG

Enrollment

1,859 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Coronary Syndrome Myocardial Ischemia Coronary Artery Disease Ischemic Heart Disease Angina Pectoris Atherosclerosis, Coronary

Summary

The objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Freesolve RMS and a medical device called Xience DES for people with acute coronary syndrome, angina pectoris, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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